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Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm

NCT06432452 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-18

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to assess if adjunctive bosentan therapy, in comparison to placebo, can reduce the rate of epicardial vasospasm at follow-up spasm provocation CFT (fuCFT) in patients with previously proven epicardial vasospasm on acetylcholine reactivity testing (at index CFT) and ongoing angina(-like) complaints.

Participants will

* Use either endothelin receptor antagonist or placebo for 10 weeks
* Undergo follow-up acetylcholine spasm provocation test after 10 weeks
* Answer online questionnaires on angina and quality of life

Conditions

  • Coronary Spasm

Interventions

DRUG

Endothelin Receptor Antagonist

Oral capsules twice daily

OTHER

Placebo control

Oral capsules twice daily

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Catharina Ziekenhuis Eindhoven

    collaborator OTHER

  • Maasstad Hospital

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Peter Damman, MD, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-11
Primary Completion
2026-06-15
Completion
2026-07-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06432452 on ClinicalTrials.gov